Grant Funding

Faculty Disclosure

Disclaimer

Pharmacist Post Test

1. Don is a 72-year-old who is looking online for alternatives to self-manage his pain. His prescriber told him he would not write any other prescriptions for oxycodone with APAP. He is looking at kratom and for Canadian Pharmacies that don’t require a prescription. Which of the following is the motivator for Don to transcend the normal medication supply chain?

1. Cost of prescription options
2. Circumvent prescriber gatekeeping restrictions
3. Embarrassment over his health issue

1. You are a pharmacist at a community pharmacy and a patient asks you which supplements to buy. What is a validated way to assure the dietary supplement you recommend does not have excessive microbial or heavy metal contamination and has the ingredients in the tablets/capsules advertised on the label?

1. USP certification
2. Better Homes and Gardens Certification
3. The most expensive one

1. Sylvia is a 68-year-old woman who weighs 120 pounds but wants to weigh 108 pounds like she did when she was 40 years old. Which of the following is a good counseling point if she reveals she is using a “peptide” GLP-1 product?

1. Her obesity is a disorder that requires a GLP-1 product, so the benefits outweigh the risks
2. These products are known to contain lead and arsenic in too high a level
3. The labeled dose could vary, and she could overdose or underdose as a result

1. Don from question 1 finds a “pharmacy” willing to sell him oxycodone with APAP for $7 a pill without a prescription. The site says it is a best seller in Canada. What is the main risk of Don getting his opioids from the unlicensed online site?

1. Fentanyl adulteration and dose variability could lead to respiratory depression
2. It is more expensive than the brand name prescription version he now takes
3. The company offers no certificate of analysis or money back guarantee

1. A company says its melatonin supplement can “support a restful sleep” and that “this product is not intended to diagnose, evaluate, or treat any disease.” What would the FDA call this?

1. A legitimate health claim
2. A legitimate quasi health claim
3. A legitimate semi-health claim

1. A woman calls a company that sells “Energy Macha” to complain that her newborn has an extra arm with seven fingers. How long does the company have to alert the FDA about this serious potential adverse event?

1. 1-day
2. 5-days
3. 15-days

1. Which of the following common adulterants is matched with the type of dietary supplement it is associated with?

1. Weight Loss – human growth hormone
2. Muscle Building – sildenafil
3. Sexual Enhancement – tadalafil

1. What is the name of the law that controls FDA authority over dietary supplements?

1. DSHEA 1994
2. OBRA 1990
3. FDCA 1927

VIDEO

Grant Funding

Faculty Disclosure

Disclaimer

LAW: Call  1-800-Get-Cash Fast

After completing this continuing education activity, learners will be able to

• Explain common terminology associated with commercials targeting older Americans
• Describe legal processes associated with lawsuits generated against companies that make products alleged to cause harm
• Discuss generalities in potential lawsuits associated with media promotion campaigns
• Identify areas where no information is available to provide good, valid answers for patients who ask questions

1. What is the legal lingo for cases that are solicited on television using 1-800 numbers?

1. Class action suits
2. Torte claims
3. Product liability suits

2. What groups have traditionally been represented in parens patriae suits?
3. State residents who appeal to the state to represent them
4. Smokers and people who have opioid or alcohol use disorder
5. Children, the mentally ill, people who are legally incompetent

3. What is usury law?

1. Laws pertaining to the use of a commercial product that results in alleged harm to a group of people who become plaintiffs
2. Laws pertaining to  lending money at an interest rate that is unreasonably high or higher than the rate permitted by law
3. Laws pertaining to any claim that arises in civil court, with the exception of contractual disputes, property, or criminal activity

4. When discussing multi-district litigation (MDL), what does the adjective “generic” mean?

1. It means that most torte claims do not include generic drugs; they focus on brand names
2. It means assets (documents, expert opinion, interviews, etc) that apply to all plaintiffs
3. It means developing charts, timelines, and visuals that a judge and jury will understand

5. A patient asks you if you can determine how much money he might get if he joins a multi-district litigation on ranitidine. What do you say?

1. Call the 1-800 number advertised on TV; the operator can provide that information.
2. Go to the local library and access LegalTrac; settlement amounts are tracked closely.
3. That information is guarded closely by nondisclosure agreements; it’s hard to tell.

6. What is the Texas Two-Step in the legal arena?
7. A term describing division of assets and liabilities between two companies
8. A term describing a non-opt-out settlement for mass tort liability
9. A term describing companies’ tendency to declare bankruptcy swiftly

7. In a case against a major pharmaceutical company that made a liquid cherry flavored gastroprokinetic drug for adults, who received the lion’s share of the settlement?

1. The patients/plaintiff
2. The attorneys
3. Others

VIDEO

Grant Funding

Faculty Disclosure

Disclaimer

Post Test
2023 CE Finale – LAW: Off-Label Drug Use and the Pharmacist’s Role

1. Which of the following statements about off-label drug use is TRUE?
a. Connecticut’s Pharmacy Practice Act prohibits a pharmacist from dispensing a drug for a use other than its FDA-approved indication.
b. Drug companies have a First Amendment (“free speech”) right to promote FDA-approved drugs for unapproved indications.
c. Pharmacists who have declined to fill a prescription for an unapproved use have been found liable for interfering with the prescriber-patient relationship.

2. According to the FDA, which of the following statements about unapproved drugs and unapproved uses of approved drugs is FALSE?
a. Unapproved drugs have not been cleared as safe and effective by the FDA.
b. All drugs compounded pursuant to a prescription are unapproved drugs.
c. The importation and use of an unapproved drug is prohibited in all circumstances.

3. According to the Agency for Healthcare Research and Quality (AHRQ), off-label prescribing accounts for approximately what percentage of all prescriptions in the United States?
a. 3%
b. 20%
c. 40%

4. A patient asks the pharmacist to mix up some “Magic Mouthwash” consisting of two FDA-approved OTC medications (such as Benadryl liquid and Mylanta) to treat mouth sores. What should the pharmacist tell the patient?
a. The pharmacist needs to do some research; if research indicates this product is effective, he can make it.
b. A prescription is needed because the pharmacist is compounding two FDA-approved drugs for an unapproved use.
c. The pharmacist can make Magic Mouthwash because both medications are OTC (not prescription-only).

5. Which of the following statements about pharmacist responsibilities when dispensing FDA-approved drugs for an unapproved use is TRUE?
a. Unless it’s a prescription for a compounded drug, a pharmacist is obligated to verify the intended use of each drug that is dispensed pursuant to a prescription.
b. When a pharmacist recognizes that a prescription is for an off-label use, the pharmacist is obligated to inform the patient that the use is not approved by the FDA.
c. If a pharmacist recommends an off-label use of a drug to a prescriber, the pharmacist should be aware of evidence-based support for the use.

VIDEO